BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3900848 · Received June 27, 2014

    Report

    Report Number
    3004209178-2014-12243
    Event Type
    Injury
    Date Received
    June 27, 2014
    Report Date
    June 4, 2014
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT # J0301144V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 3095-10, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 3889-28, LOT # J0301144V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN HAVING PROBLEMS FOR THE LAST 3-4 YEARS AND EVEN WITH THE CHANGE OUT THE PATIENT WAS STILL HAVING BAD LEG PAIN AND THEIR BACK WAS HURTING EVEN MORE NOW BECAUSE WHEN THE HEALTHCARE PROVIDER PUSHED THE WIRES IN MORE BECAUSE THEY WERE PROTRUDING OUT OF MY BACK, HE STRAIGHTENED MY BACK BECAUSE I WAS A HUNCHBACK. THE PATIENT REPORTS A SHOCKING OR JOLTING SENSATION. THE PATIENT ALSO STATED THAT WHEN SHE GOES THROUGH SECURITY GATES AT STORES SHE WILL GET A SHOCK SO SHE SAYS SHE ALWAYS BRINGS HER CONTROLLER WITH HER. THE PATIENT STATES THAT SHE HAS EXPERIENCED THIS EVER SINCE SHE HAS HAD AN INTERSTIM IMPLANTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR HEALTHCARE PROVIDER OR MANUFACTURER REPRESENTATIVE. IT WAS NOTED THAT THE PATIENT APPOINTMENT WAS SCHEDULED FOR (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377371 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT SOFAMOR DANEK PUERTO RICO MFG 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention